Many physicians are unfamiliar with how the Food and Drug Administration's (FDA) regulates new drugs and medical devices, and they may be under the impression that the data supporting these approvals are more rigorous than ...
Jan 9, 2024
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A new Northwestern University study—led by Bernard Black of Northwestern's Pritzker School of Law and Kellogg School of Management—suggests that the U.S. could have saved many lives by authorizing a COVID-19 booster dose ...
Dec 5, 2023
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For patients with advanced or metastatic non-small cell lung cancer (NSCLC) and limited performance status, an immune checkpoint inhibitor drug called durvalumab is safe and may benefit overall survival, according to a new ...
Nov 21, 2023
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Of the 198 new oncology drugs approved by the U.S. Food and Drug Administration (FDA) between 1998 and 2022, approximately 43% were precision oncology therapies, the use of which is guided by biomarker testing.
Oct 18, 2023
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The German Institute for Quality and Efficiency in Health Care (IQWiG) has responded critically to a reflection paper by the European Medicines Agency (EMA) on the approval of new drugs based on single-arm studies.
Oct 6, 2023
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The U.S. Food and Drug Administration (FDA) recently approved palovarotene (Sohonos) as the first treatment for fibrodysplasia ossifcans progressiva (FOP), a severely disabling condition that causes abnormal bone formation ...
Oct 2, 2023
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A top UVA Health cancer expert is highlighting how a new drug could transform how doctors treat a brain tumor that typically strikes younger people.
Sep 29, 2023
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The U.S. Food & Drug Administration has approved Akeega (niraparib and abiraterone acetate) for the treatment of BRCA-positive metastatic castration-resistant prostate cancer.
Aug 18, 2023
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The U.S. Food and Drug Administration has approved Talvey (talquetamab-tvgs) for patients with relapsed or refractory multiple myeloma.
Aug 16, 2023
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The US drug regulator gave full approval to a new Alzheimer's medicine on Thursday, a move that makes it more widely available to the public through government-run health insurance for the elderly.
Jul 7, 2023
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